The EWG's success is evidenced by the ready adoption by pharmaceutical companies, the industry in general, and by the many public presentations, training courses, and journal articles. Almost all pharmaceutical companies have a quality-risk management (QRM) program at some stage of development. The close relationship of ICH Q9 with ICH Q8 Pharmaceutical Development, and ICH Q10 Pharmaceutical Quality System has further solidified wide spread utilization of QRM in practical applications.
QRM and patient protection
ICH Q9 does comment on the role of the patient in the structure of the QRM program, but that context is limited. It is implied, but not actually said, that QRM means management of risk to the patient. The word patient occurs only seven times in the document; twice the patient is referred to as a stakeholder, twice regarding protection of the patient, once as an interested party, once regarding patient need, and once regarding high-quality drugs. Patient and risk are not mentioned together. By contrast, the phrase "Quality Risk Management" occurs 81 times.
It is assumed that the EWG intended that QRM would reduce risk to the patient, but the majority of industry readers may not recognize that assumption and may implement Q9 with an emphasis on management rather than on risk to the patient; obviously two different goals.
Q9 needs to be more explicit in its goal of patient risk minimization (PRM). This can be achieved by simply replacing the words "quality risk management" where they occur in the current version with "patient risk minimization." The shift from quality to patient and from management to minimization would refocus the entire quality program from internal to external and would further support the lifecycle concept of validation.
The risk to quality would still be managed by minimizing the risk to the patient. For example, a sentence in Q9 reads: "... the protection of the patient by managing the risk to quality should be considered of prime importance" (1).
Now consider the focus of this restatement: "The enhancement of quality by minimizing the risk to the patient should be considered the prime objective." Notice how this change shifts the focus from risk management to risk minimization. This revised statement has the additional benefit of implying continuous improvement and not just maintaining the status quo.
The shift from static management of quality to continuous reduction in patient risk, suggests the addition of statistically oriented tools and concepts. A new version would benefit greatly with these statistical inclusions:
Note that in the field of statistics, the Type II error and the LQ are associated with the concept of patient or consumer risk. Minimizing these risks is inherent in good data design, collection, and analysis.
It is an opportune time to sharpen the focus on patient risk now that a measure of success with quality risk management has been achieved. Replacing the term "quality risk management" with "patient risk minimization" is one way to move to the next level of patient protection while building on the current strong base of ICH Q9.
1. ICH, Q9, Quality Risk Management (2005).
2. ISO/IEC Guide 73:2002.